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Gadofosveset trisodium Side Effects

For the Consumer

Applies to gadofosveset trisodium: intravenous solution

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Very bad dizziness or passing out.
  • A heartbeat that does not feel normal.
  • A fast heartbeat.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to gadofosveset trisodium: intravenous solution

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis and anaphylactoid reactions.[Ref]

Dermatologic

Dermatologic side effects have included pruritus.[Ref]

Local

Local side effects have included injection site bruising, burning sensation, and venipuncture site bruise.[Ref]

Nervous system

Nervous system side effects have included headache, paresthesia, and dizziness (excluding vertigo).[Ref]

Cardiovascular

Cardiovascular side effects have included vasodilatation and hypertension.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and dysgeusia.[Ref]

General

General side effects have included feeling cold.[Ref]

References

1. "Product Information. Vasovist (gadofosveset trisodium)." Bayer Pharmaceutical Inc, West Haven, CT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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